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I I. B.- T R E A T M E N T P L A N: DOCETAXEL 75 mg/m2 40 mg/m2 THORACIC RT (66 Gys: 180 cGy/d) CISPLATIN 40 mg/m2 Days 1 2 22 36 50 64 92 E V A L U A T I O N www.cancerpulmongalicia.org IASLC, 15 TH WCLC 2013; Sydney: # 1010 I I I.- R E S U L T S: I I I. A.- Patients Characteristics (n = 53) C O N C L U S I O N S: CONCURRENT CHEMORADIATION WITH BI-WEEKLY DOCETAXEL AND CISPLATIN AND THORACIC RADIOTHERAPY, AFTER ONE CYCLE OF INDUCTION CHEMOTHERAPY WITH D-C, IS A FEASIBLE TREATMENT OPTION FOR IRRESECABLE LOCALLY ADVANCED STAGE III A – III B NON SMALL CELL LUNG CANCER. AN GOOD CLINICAL ACTIVITY, TOLERABILITY AND MEDIAN OVERALL SURVIVAL WERE OBSERVED. AN ACCEPTABLE LONG TERM SURVIVAL WAS ACHIEVED. I I I. B.- T O X I C I T Y (per p) Median age (range), years 59,4 (34 – 75) Sex Male Female 47 (88 %) 6 (12 %) ECOG (Performance Status) 0 1 17 (31,4 %) 36 (68.6 %) Histology Squamous Adenocarcinoma Large cell 28 (52.8 %) 18 (33.9 %) 7 (13.3 %) Stage III A T1-3 N2 15 (28.3 %) Stage III B T4 N0-2 T1-3 N3 T4 N3 27 (50.9 %) 7 (13.3 %) 4 (7.5 %) Weight loss < 5%6 (11.3 %) Evaluable Response Toxicity 53 (100 %) TOXICITIESg 1-2g 3 neutropenia28.55.6 anemia62.20 esophagitis50.93.7 pneumonitis320 n/vomiting20.70 fatigue37.73.7 4 hospitalizations: febrile neutropenia: 2 p g3 Esophagitis: 2 p I I I. D.- T H E S U R V I V A L C U R V E S (KAPLAN-MEIER): “CONCURRENT CHEMORADIATION (CChRT) FOR STAGE III NON-SMALL CELL LUNG CANCER (NSCLC): A PHASE II STUDY FROM GALICIAN LUNG CANCER GROUP” J. Casal 1, C. Ponte 2, C. Senín 1, B. Campos 3, XL. Firvida 4, M. Carmona 5, E. Hernández 6, MD. López 7, I. Formoso 2, M. Lázaro 1, S. Vázquez 3, MC. Areses 4, C. Rodríguez 5, C. Pena 8, MJ. Villanueva 1 1 Sº Oncoloxía Medica (OM) Complexo Hospitalario Universitario (C. H. U.) de Vigo, Spain; 2 Sº Oncoloxia Radioterápica (OR) C.H. U. de Santiago, Spain; 3 Sº OM H. U. Lucus Augusti de Lugo, Spain; 4 Sº OM. C.H. U. de Ourense, Spain; 5 Sº OM C.H. U. de Santiago, Spain; 6 Sº OR C.H.U. de Vigo, Spain; 7 Sº OR C.H.U. de Ourense, Spain; 8 Sº OM C.H. de Pontevedra, Spain. Induction chemotherapy C C h R T follow - up b) CChRT: 50 p: D-C doses: 203 (3.8 per p) mean RT doses: 64,6 Gy (41-66.6) RESPONSEP%95% CI CR611.3 PR3769.8 OR4381.871 - 92 SD47.6 PD611.3 I I I. C.- E F F I C A C Y (%) : a) INDUCTION D-C: 53 cycles (1 per p) SURVIVALMEDIAN (months) 95% CI1 year % 2 years % 3 Years % OS219 - 3281.849.730.2 SLPR1411 - 1755.131,8n.a. TOXICITIESg 1-2g 3-4 neutropenia1.815 anemia11.30 n/vomiting26.41.8 diarrhea22.63.7 fatigue35.80 stomatitis12.90 2 hospitalisations: febrile neutropenia: 1 p g3 diarrhea: 1 p I.- B A C K G R O U N D: I.- B A C K G R O U N D: Combined cytotoxic chemotherapy and radiation therapy is established as the standard treatment for patients with medically inoperable or technically unresectable stage III NSCLC. Multiple randomized studies and meta-analyses demonstrate that CChRT results in improved survival compared with sequential chemo-radiotherapy or radiotherapy alone. A clearly superior regimen has not identified. Docetaxel (D) has been shown to posess good single activity against NSCLC as well as radiosensiziting properties both alone and sinergistically with Cisplatin (C). The aim of our study was to evaluate the effectiveness and toxicities of CChRT with bi-weekly Docetaxel (D) and Cisplatin (C) and thoracic radiotherapy, after one cycle D-C induction chemotherapy. I I. A.- M A T E R I A L A N D M E T H O D S: I I. A.- M A T E R I A L A N D M E T H O D S: SELECTIVE SELECTIVE CRITERIA: - Age < 75 years. - Histological confirmation. - Stage: IIIA – IIIB (except pleural effusion T4) (AJCC’97). - Evaluable or measurable disease. - PS 0-1 (WHO grade). - Normal organic functions; - FEV1 > 1.1 litres. V20 < 25%. - Weight loss < 5 %. - No previous treatment or serious underlyne disease. 50 patients (p) with locally advanced NSCLC were included from June/2009 to July/2012. MEDIAN FOLLOW-UP: 17,8 Months. A B S T R A C T T E X T Background: Combined cytotoxic chemotherapy and radiation therapy is established as the standard treatment for patients with medically inoperable or technically unresectable stage III NSCLC. Multiple randomized studies and meta-analyses demonstrate that CChRT results in improved survival compared with sequential chemo-radiotherapy or radiotherapy alone. The aim of our study was to evaluate the effectiveness and toxicities of CChRT with bi- weekly Docetaxel (D) and Cisplatin (C) and thoracic radiotherapy, after one cycle D-C induction chemotherapy. Methods: Between May 2009 and November 2012, 53 chemo-naive p with histologically confirmed inoperable locally advanced NSCLC, stage IIIAN2/IIIB (no pleural T4), PS 0-1 and adequate lung function (FEV1 > 1.1, V20 < 25%) were included: one cycle of D 75 mg/m2 on day 1 and C 40 mg/m2 days 1-2 followed at 21 days by CChRT with bi-weekly D 40 mg/m2 and C 40 mg/m2 for four courses, during conformal thoracic radiotherapy (66 Gys, 180 cGy/day). The primary objective was overall survival (OS); secondary objectives were progression free survival (PFS), response rate (RR) and toxicity. Median follow-up: 17,8 months. Results: The p characteristics were: mean age 59,4 years (34-75); male/female 47/6; ECOG PS 0/1 in 17/36 p; squamous/adeno/large cell carcinoma: 53%/34%/13%; stage IIIAN2 15 p (28.3%) and stage IIIB 38 p (71.7%). All p were evaluable for response and toxicity. RR: 6 CR, 37 PR (RR 81.8%; 95% CI:71-92), 4 SD (7.6%) and 6 PD (11.3%). The median PFS was 14 months (95% CI:11-17) and median OS was 21 months (95% CI:9-32). The PFS at 1/2 years were 55%/32% and the OS at 1/3 years were 82%/50%. A total of 53 cycles of D-C induction chemotherapy were given; main toxicities (NCI-CTC 3.0) per p Grade (g) 1-2/3-4 (%) were as follows: neutropenia 1.8/15; anemia 11.3/0; nausea/vomiting 26.4/1.8; diarrhea 22.6/3.7; fatigue 35.8/0; there were three episodes of hospitalization: febrile neutropenia 2 p and g3 diarrhea 1p. Main toxicities per p in CChRT (D-C doses: 203, 3.8 per p; mean doses RT: 64,6 Gys) were g1-2/3 (%): neutropenia 28.3/5.6; anemia 62.2/0; esophagitis 50.9/3.7 and pneumonitis 32/0; nausea/vomiting 20.7/0; fatigue 37.7/3.7; there were four episodes of hospitalization: febrile neutropenia, 2 p and g3 esophagitis, 2 p. Conclusion: CChRT with bi-weekly Docetaxel and Cisplatin and thoracic radiotherapy is a feasible treatment option for inoperable locally advanced stage III NSCLC, showing good clinical efficacy and tolerability with acceptable long-term survival. PRIMARY OBJECTIVE: Overall survival (Kaplan-Meier) SECONDARY: Progresion free survival, (Kaplan-Meier). Response rate (Recist). Toxicity (CTC-NCI v3.0 and RTOG.
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